Three-Year Results of Safety and Efficacy of the Everolimus -Eluting Coronary Stent in Women (from the SPIRIT III Randomized Clinical Trial)

• Published in: The American journal of cardiology 2011-03, Vol.107 (6), p.841-848
• Main Authors: Ng, Vivian G., MD, Lansky, Alexandra J., MD, Hermiller, James B., MD, Farhat, Naim, MD, Applegate, Robert J., MD, Yaqub, Manejeh, MD, Sood, Poornima, MD, MBA, Su, Xiaolu, MS, Simonton, Charles A., MD, Sudhir, Krishnankutty, MD, PhD, Stone, Gregg W., MD
• Format: Article
• Language: English
• Subjects: Biological and medical sciences; Cardiology; Cardiology. Vascular system; Cardiovascular; Cardiovascular disease; Clinical outcomes; Clinical trials; Comparative analysis; Coronary Disease - drug therapy; Coronary heart disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Heart; Humans; Immunosuppressive Agents - administration & dosage; Male; Medical sciences; Middle Aged; Paclitaxel - administration & dosage; Patient safety; Prospective Studies; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Sex Factors; Single-Blind Method; Sirolimus - administration & dosage; Sirolimus - analogs & derivatives; Stents; Treatment Outcome; Tubulin Modulators - administration & dosage; Women
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/j.amjcard.2010.10.068

Women treated with the XIENCE V have improved 1-year clinical outcomes compared to women treated with TAXUS; whether benefits in women are sustained at 3 years is unknown. Three-year follow-up of the SPIRIT III trial revealed improved clinical outcomes of the XIENCE V everolimus-eluting stent compared to the TAXUS paclitaxel-eluting stent. One thousand two patients with coronary artery lesions ≤28 mm in length in 2.5- to 3.75-mm diameter vessels were prospectively randomized to receive XIENCE V or TAXUS stents. A post hoc gender subset analysis was performed. Six hundred sixty-nine patients (30% women) received XIENCE V and 332 patients (34% women) received TAXUS. In the overall population, women had higher 3-year rates of major adverse cardiac events (16.0% vs 10.0%, p = 0.01) and target lesion revascularization (10.2% vs 5.3%, p = 0.008) compared to men. In women, those with XIENCE V continued to have lower major adverse cardiac event rates than those with TAXUS at 2 years (9.5% vs 18.3%, p = 0.03) and 3 years (12.2% vs 22.6%, p = 0.03). Although 1-year target vessel failure rates were similar, at 2- and 3-year follow-up women treated with XIENCE V had approximately 40% relative decreases in target vessel failure rates compared to those treated with TAXUS (12.7% vs 22.0%, p = 0.05; 16.0% vs 26.4%, p = 0.03, respectively). Stent thrombosis and bleeding complication rates were similar between treatment arms in the gender subgroups through 3 years. In conclusion, women in the SPIRIT III trial have sustained clinical benefits from XIENCE V implantation compared to TAXUS without increases in long-term complications.